RENEWAL APPLICATION FORM

 

URGENT UPDATE: The IRB will no longer accept Renewal Applications after a protocol expires.  There will be no “grace period” for a Renewal Application received after the Expiration Date of the protocol.  The UMCP IRB and Federal Regulations do not permit extensions of human subject research projects beyond the IRB Approval dates.

 

If you would like to continue obtaining data from human subjects or collecting or analyzing identifiable private information for a human subjects research project, a Renewal Application must be reviewed and approved by the Institutional Review Board (IRB) prior to the expiration date for the previous IRB approval.

 

However, if the Renewal Application is submitted prior to the Expiration Date this does not guarantee the application will receive IRB Approval before the protocol expires.  If the protocol does expire after a Renewal Application has been submitted, all research activities involving human subjects must cease until approval is granted. If a Renewal Application is not received by the IRB Office prior to the Expiration Date, the protocol will expire and a New (Initial) Protocol Application must be submitted and approved in order to continue human subject research activities. 

 

Determining if Renewal is Required

Please consider the following questions when determining if a Renewal Application or Closure Report must be submitted.  If you have any questions, please contact the IRB Office.

 1) Will future research activities involve obtaining data through intervention or interaction with human subjects?

 2) Will future research activities involve obtaining identifiable private information about living individuals? Information is identifiable if subjects can be identified directly or through identifiers linked to the subjects.  This includes any lists of participants that have not yet been destroyed.

 3) Will future research activities include analyzing identifiable private information about living individuals?

 

PLEASE NOTE: If you answered yes to any of these 3 questions, a Renewal Application must be submitted for your research project.

 If you answered no to all of the above questions, a Renewal Application is not required and a Closure Report must be submitted.  A protocol is eligible for closure if:

 a) data collection is complete

b) there is no more participant contact (including follow-up interviews, calls, surveys)

c) the only research activity remaining is data analysis of de-identified data.

 Please click here to submit a Closure Report: Closure Report Form

 

   Download Renewal Application Form  

  Download Consent Form



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